Apparatus and methods of making denture devices

ABSTRACT

The present application describes a method for designing and manufacturing a denture device for a patient. A method is described for designing a virtual denture and manufacturing a functional fitting replica denture from the virtual denture. An apparatus comprising a functional fitting replica denture is prepared having denture teeth having a fit substantially similar to the final denture. The methods and apparatus described herein reduce the number of visits required to manufacture the final denture.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional and claims priority under 35 U.S.C.§119(e) to patent application Ser. No. 14/142,382, titled “Apparatus andMethods of Making Denture Devices” filed on Dec. 27, 2013, which isincorporated herein by reference in its entirety.

This application is related to U.S. patent application Ser. No.14/142,393, which is herein incorporated by reference in its entirety.

BACKGROUND

Fabricating a well-designed denture set to replace missing teeth in anedentulous patient is both challenging and time consuming, requiringnumerous visits between a patient and a healthcare professional.Moreover, impressions and models are sent back and forth between ahealthcare professional and a dental laboratory to achieve a fit andaesthetics satisfactory to dentist and patient, impacting the timerequired to prepare the final denture.

Traditionally, patient visits are necessary to take impressions of apatient's edentulous ridge, to evaluate the fit of a try-in denture, tocheck the bite relationship of a try-in denture, and to ensure accuratefit of the final denture. In a first visit, an impression of a patient'soral anatomy is taken which is used by the dental laboratory to form astone model of the patient's maxillae and mandible, providinginformation regarding features such as the size and shape of edentulousridges. Optionally, custom trays may be made from the stone model fortaking a final impression in a subsequent patient visit. In a furthervisit, a patient's bite registration is taken to determine therelationship between mandible and maxillae by inserting wax rims intothe oral cavity of a patient. The bite registration information is sentto the dental laboratory for preparation of a try-in denture. The try-indenture is usually composed of a wax denture in which final dentureteeth have been hand-set by a laboratory technician.

In further visit, the patient is examined with the wax try-ins for fitand appearance, and the health care professional notes any adjustmentsthat may be required before preparation of the final denture. After allfinal adjustments are made, a dental laboratory prepares the finaldenture set based on the wax try-in. As a result of limitations in thisprocess, sometimes the fit of the final denture is inadequate, requiringre-manufacturing of the dentures, repeating all or part of this process.

There is a need to reduce the expense and time required to prepare afinal denture set. Savings in time and money can be achieved by reducingthe number of visits between the patient and the healthcareprofessional, and reducing the time it takes the dental laboratory tomake a final denture.

It is advantageous to make dentures by methods that reduce thelimitations inherent in traditional manufacturing processes. Creatingvirtual designs by computer-aided design (CAD) methods is effective forreducing the time to make dental restorations. CAD designs complementedby the use of patient data are known for use in dental restorations.Digital patient data may be obtained directly from a patient's mouth bya handheld scanner, or from scan data of negative impressions, fromstone models made from the impressions of a patient's mouth.Additionally, input from a virtual library of teeth shapes have beenused in conjunction with patient data to create dental restorations. CADdesign methods can enhance both the shape and function of therestoration. Optical and contact digitizers used to provide virtual dataof a patient's oral anatomy are described in the literature, and someare commercially available.

CAD design used in conjunction with computer-assisted manufacturing(CAM) is known in dental restorations. Automated manufacturing processesinclude both subtractive and additive processes. Additive processesinclude those known by terms such as three-dimensional (3D) printing,additive manufacturing, rapid prototyping and rapid manufacturing, andinclude processes of forming a three-dimensional solid objects from avirtually designed digital model. Additive manufacturing processes, suchas 3D printing, are distinct from machining or milling techniques thatrely on removal of material by cutting or drilling (a subtractiveprocess).

In 3D printing, a virtual or digital representation of an object isreduced to a physical form by depositing material in a patterncorresponding to a cross-sectional layer of the object. Material whichis sufficiently flowable, either as a liquid, or a solid that can berendered flowable, may be formed layer by layer by a 3D printer. Theflowable material is solidified and Subsequent layers are formedthereon. Cross-sections of the virtual representation of the object areused to form each layer, for example, by moving a print head over a workpiece and activating elements of the print head to create a layer of theobject. Printing may be performed by any method known in the art to formlayers that ultimately result in a solid object.

Where a liquid is used, a material such as a polymerizable liquidmaterial is printed according to the digital representation. The liquidis hardened in the required pattern, for example by cross-linking, orwhere a molten thermoplastic material is used, by cooling. Uponsufficient hardening or crosslinking of a first layer, subsequent layersare printed and hardened.

The liquid level is raised a short distance and the process is repeated.Each layer corresponds to a cross-section of the virtual representationand a cross-section of the object to be formed. In a further method, theliquid material may be applied as drops in a pattern according to thecross-sectional object to be formed.

In another method, powder is used, instead of liquid, to form thethree-dimensional (3D) object. Powder, applied to a substrate in apattern corresponding to a layer of a digital representation, ishardened by any known method suitable for the selected powder such asheating. Each layer of a 3D object may be created by spreading a thinlayer of powder over the surface of a powder bed and hardened orpartially hardened as each layer is laid down. Subsequent layers ofpowder are laid down in sequence upon coalescing of the initial layer toa stable form. Whether liquid or powder, material deposition iscontrolled by a computing device, such as a computer, personal computer,microcontroller, or the like.

Automated manufacturing processes, used in combination with virtualdesign process, standardize the manufacturing process and realize bothtime and cost savings in dental restoration production.

SUMMARY

The present invention describes a method for designing and manufacturinga final denture for a patient. A method is also described for designinga virtual denture, as well as a method for manufacturing a functionalfitting replica denture from the virtual denture. An apparatus isdescribed that comprises a functional fitting replica denture made froma physical model of the virtual denture with actual denture teethpositioned in the physical model. Also described is a method for makingthe functional fitting replica denture that reduces the number of stepstaken to manufacture a final denture. Further described is an apparatusfor determining the vertical dimension of occlusion in a patient.

In accordance with methods described herein, a virtual denture isdesigned via CAD methods combining information from a patient's oralanatomy and a virtual denture teeth design. Described herein is aplurality of virtual denture teeth designs wherein each design has ateeth set that is prearranged in a fixed position in an occlusal schemecorresponding to a specific arch shape and a specific size. Theplurality of virtual denture teeth designs have been designed based onan analysis of measurements of accumulated data from previously madedentures. Thus, automatic generation of a virtual denture design may beachieved based on similarities between a new patient and designsprovided for in the library. Methods for designing virtual denturesinclude the step of selecting a virtual denture teeth design from aplurality of designs that correspond to the size and shape of thepatient's oral anatomy.

The method for designing the virtual denture comprises accessing data ofthe patient's oral anatomy, such as size and shape of the patient'smaxillae and mandible, to select a pre-designed virtual denture teethdesign from a plurality of designs, thereby automatically generating adesign that fits the size and shape of the patient's oral anatomy. It isadvantageous that a virtual denture can quickly achieved by selecting apre-designed virtual denture teeth design that is compatible with thesize and shape of the patient's oral anatomy.

Once completed, the virtual denture defines parameters that are used inautomated manufacturing processes to form a physical model of thevirtual denture. Additional parameters specific to the individualpatient, such the topography of gingiva and characteristics of the softpalate, can be incorporated into the virtual design to enhance the fitand appearance denture. These features, formerly traditionally designedby hand by a laboratory technician, can be virtually designed andtranslated directly to a physical model, for example, by an additivemanufacturing process.

The physical model can be modified by the addition of denture teeth inone or more regions to make a functional fitting replica denture. Amethod is described for making a functional fitting replica denture thathas actual denture teeth precisely aligned in a formable materialreplicating the placement of teeth from the virtual denture. Afunctional fitting replica denture made by setting teeth and forming agingival architecture by automated processes can achieve a better fitthan a typical try-in denture by accurately replicating the uniquecharacteristics of the patient. Unlike traditional methods of forming atry-in, which include manual or hand-setting of denture teeth and themanual wax-up of the gingival part by a technician, automated processesare precise, repeatable and accurately reflect the features of apatient's oral anatomy. In contrast to a traditional try-in denture, thefunctional fitting replica denture can be used to accurately check biteregistration. Because it is functional, the patient can bite and/or chewwith the device in place without destruction of the set-up or crushingof the wax used in traditional try-ins. Moreover, the functional fittingreplica denture replicates the fit and structure of the gingivalportions of a final denture with regard to size and shape, as well asthe occlusal scheme and alignment of the final teeth.

Further described herein are methods for using a functional fittingreplica denture to obtain bite registration data. Traditional materialsused in obtaining bite registration data include using a pair of waxbite rims that is bulky and does not fit well within a patient's oralcavity, often resulting in inaccurate measurements. Methods forobtaining bite registration data are described herein that increase theaccuracy of the data by replacing an upper and/or lower bite rimmaterials with an upper and/or lower functional fitting replica denturemade by the described methods. Methods for obtaining bite registrationdata result in more accurate vertical dimension of occlusion and biteregistration measurements.

As used herein, a denture device includes one or more of a final denture(full denture or partial denture), a physical model of a denture, afunctional fitting replica denture, or an apparatus forbite-registration. The physical model of a denture describes anapparatus that has been constructed by any process, including and notlimited to methods known by the terms subtractive manufacturing,additive manufacturing, rapid prototyping, rapid manufacturing,three-dimensional printing (3D printing), stereo lithography, and thelike. The term functional fitting replica denture describes an apparatusconstructed from the physical model by methods mentioned above, that hasbeen further processed to include actual denture teeth. Denture teethdescribe actual artificial denture teeth that are typically used in afinal denture restoration. The terms physical model of a denture,functional fitting replica denture, denture device, final denture and anapparatus for bite registration, are intended to optionally include anupper portion for insertion onto the maxillae of a patient, a lowerportion for insertion onto the mandible of a patient, or a denturedevice comprising both an upper portion and lower portion.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1. A denture device according to an embodiment described herein.

FIG. 2. A functional fitting replica denture according to an embodimentdescribed herein.

FIG. 3. A virtual denture teeth design and virtual gingival boundaryaccording to one embodiment.

FIG. 4. A bite registration apparatus according to an embodimentdescribed herein.

FIG. 5. A block diagram of a computing system according to oneembodiment described herein.

FIGS. 6a-6d . A virtual denture according to one embodiment describedherein.

FIGS. 7a-7c . A virtual denture according to one embodiment describedherein.

FIGS. 8a-8c . A virtual denture according to one embodiment describedherein.

FIG. 9. A virtual denture according to one embodiment described herein.

FIG. 10. A virtual denture according to one embodiment described herein.

FIG. 11. A screen view of one embodiment of a virtual denture teethdesign and a 3D representation of a stone model of a patient's oralanatomy according to an embodiment described herein.

FIG. 12. A view of one embodiment of a physical model described herein.

FIGS. 13a and 13b . A view of one embodiment of a mold on a physicalmodel described herein.

FIG. 14. A view of one embodiment of a physical model described herein.

FIG. 15. A diagram of a process described herein.

FIG. 16. A diagram of a process described herein.

While the above-identified figures set forth embodiments described here,other embodiments are also contemplated, for example, as described inthe detailed description. The figures presented are illustrativerepresentations of embodiments, and numerous other modifications andembodiments can be devised by those skilled in the art that are withinthe scope of the disclosure.

DETAILED DESCRIPTION

A method for making a denture device for placement on the edentulousridge of a patient is described. As illustrated in FIG. 1, a denturedevice (10) comprises an upper denture (11) for placement on a patient'smaxillae, a lower denture (11) for placement on a patient's mandible, orboth an upper and lower denture. A functional fitting replica denture,illustrated in FIG. 2, used for trying in the mouth of a patient priorto making the final denture, is also described. In one embodiment, avirtual denture teeth design (as exemplified in FIG. 3) is designed viaCAD methods. The virtual denture teeth design and information regardingthe patient's oral anatomy is combined by methods described herein tomake a virtual denture that is used for making a denture device. Furtherdescribed, as illustrated in FIG. 4, is a bite registration device madeby methods described herein.

In accordance with the methods set forth, the virtual 3D representationof a patient's oral anatomy may be obtained by taking an image of atleast a part of the patient's oral cavity, including the patient'smaxillae, the patient's mandible, or both the maxillae and the mandible.Image data may be collected on the entire arch, or just a portion of oneor both arches. Image data is converted to a computer generated virtualmodel of a 3D representation of a patient's present oral anatomy, and isrecorded in a data record according to known methods. Informationrelating to a edentulous patient's maxillae and/or mandible may beobtained that includes the shape and size of the maxillary and/ormandibular arches, bite relationship details of soft tissue and/orgingiva which includes characteristics such as gingival size, shape andtexture, characteristics of inner and outer gingiva, and palatalcharacteristics. When these features are incorporated into the virtualdenture, a functional fitting replica denture or final denture may beobtained having an accurate size, a secure fit onto the patient'smaxillae and/or mandible, and realistic aesthetics.

Images may be taken and recorded by known methods for obtaining,recording and converting 3D patient information into digital data filessuitable for creating a computer generated virtual 3D representation ofthe patient's oral anatomy. A three-dimensional camera, a computerizedtomography apparatus, and hand held scanning devices for scanning apatient's oral cavity may be used. Scanning systems known for obtaininginformation from the patient's oral anatomy include lOS TechnologiesFastScan® intraoral and impression scanning systems, iTero® scanningsystem (Align Technologies), ESPE True Definition Scanner (3M), and3Shape D640 scanner.

Scan data may also be obtained from a negative impression of a patient'smaxillae and/or mandible, or from a stone or plaster model made from thenegative impression by known techniques. A negative impression may bemade, using a material placed in the oral cavity usually via dentalimpression trays. Materials for making negative impressions includesodium alginate, polyether and silicones including condensation curedsilicones and addition-cured silicones, including polyvinyl siloxane(PVS). A scan of the negative impression can be provided, for example,as an array of negative image scan data generated by a scanner.

Positive image scan data may also be used, either in addition to, oralternatively to, other scan data. Positive image scan data is typicallyobtained from a stone or plaster model derived by casting the negativeimpression of the patient's maxillae and/or mandible. The stone orplaster model can be made by pouring a casting material, such as gypsumor plaster, into the negative impression. After setting, the stone orplaster model can be scanned. The stone model may be digitized by knownscanning systems, such as laser scanning, optical scanning, destructivescanning CT scanning and sound wave scanning, to obtain a digital archmodel. The stone model can also be used to determine bite registrationby alignment for example, in a dental articulator. The alignment alsocan be done virtually, with an articulator from a software program.

A bite registration apparatus may be used to obtain additionalinformation, such as vertical dimension of occlusion and biteclassification (for example, Class I, II or III). Scan data may beobtained from bite registration apparatus and the data may be used tospacially orient the maxillae and or mandible relative to one another.In a further option, data may also be obtained from previously madedentures, for example, where a replacement set of dentures is needed. Toobtain patient information, previously made dentures may be scanned byany suitable method discussed herein, such as by a desk top scanningdevice.

The scan system may provide digital data records of portions of thepatient's oral anatomy to a computing system. The digital data may beconverted from digital point clouds to 3D representations, for example3D surfaces, by means of software such as Geomagic Wrap® software (byGeomagic, Inc.) With reference to the diagram of FIG. 5, in accordanceto one embodiment, a computing system (500) is provided in which thescan data, obtained by a scanning system (501) and converted to adigital data record, is uploaded as a digital data file (502) to thecomputing system by a central processing unit (CPU) (503) and saved in amemory storage device (504). Where scan data from a negative impressionis used, software that is part of the scanning system or the computingsystem (500) may convert the scan data to a positive image for displayon a display unit (505) of a computing system (500). Negative scan dataconverted to a positive image by software and provided to CPU (503) maybe saved as a permanent digital data file (502) in a memory storagedevice (504).

The computing system (500) may further comprise a user input device(506) such as a mouse or keypad, and modem. Commercially availablesoftware packages may be stored in a memory storage device (504) andproviding executable instructions (507) to be executed by the CPU (503)to generate virtual 3D representations of the patient's oral anatomyfrom the scan data. The virtual 3D representation is obtained andrecorded in a digital data file according to known methods. Thecomputing system (500) may be a special purpose computer or a personalcomputer comprising available software packages, and the display unit(505) may include any known suitable display device such as LCDdisplays.

In one embodiment, digital data files from more than one patient imageare provided to form a digital data record of the patient's oralanatomy. A computing system (500) having software that can provideexecutable instructions to overlap and/or register images is used toassemble the plurality of scans into a computer-generated threedimensional representation of the oral cavity. Available software may beselected or developed that has instructions for overlapping andregistering the data from multiple scans, to provide digitalregistration data of the multiple scans to be used in designing avirtual denture (30) model and/or a virtual denture (FIGS. 6a -10). Inone embodiment, scan data from the patient's maxillae and/or mandible,and/or bite registration is combined by software package to provide acomplete digital data record of the patient's oral anatomy.

Virtual Denture Teeth Designs

Described herein is a method of making a plurality of virtual dentureteeth designs. With reference to FIG. 3 virtual denture teeth designs(30) have upper and lower portions of a teeth set (31, 32) prearrangedin a fixed position in an occlusal scheme corresponding to an arch shapeand size. A plurality of pre-designed virtual denture teeth designs in avariety of arch shapes and sizes may accommodate a majority of patientcases without requiring time-consuming adjustments to the position ofindividual teeth, or to the arrangement of teeth around an arch, ormodifications to size of the design. By providing a plurality ofpre-designed virtual denture teeth designs, the number of steps requiredto design a virtual denture is reduced, when compared to known methods.Because virtual denture teeth designs are pre-designed, the method stepof designing a plurality of virtual denture teeth designs is a separatemethod step from the step of designing the virtual denture whichincorporates patient-specific data.

A computer-aided design (CAD) method for creating virtual denture teethdesigns is described. In one embodiment, a user interface of a computersystem (500) may be used to actuate executable instructions (507), forexample, for viewing a library of teeth and selecting virtual teeth of aspecific size and shape from a library of teeth, and arranging thevirtual teeth in an arch shape to conform to a particular arch shape andsize to form a virtual denture teeth design. Referring to FIG. 5, thevirtual denture teeth designs may be designed via a design restorationsoftware program in a CAD system suitable for virtual dental design byuse of a computing system (500) and a system input and output interface(511). Software programs for designing dental restorations are known bydesigners of dentures and other dental restoration technicians, andprovide executable instructions (507) for use on a computing system(500). CAD software packages commercially available (such as, 3ShapeDental Designer™ program, and NetFabb® Software) may be used to generateand/or virtual denture teeth designs in a multiplicity of arch shapesand sizes that can be stored as digital data files of a design library(509) on a memory device (504).

In another embodiment, virtual denture teeth designs may be made byscanning a multiplicity of actual pre-made denture set-ups that havebeen created in specific sizes and arch shapes designed to fit amajority of denture patients. In one embodiment, the denture set-ups maycomprise a multiplicity of actual final dentures made for patients in avariety of sizes and arch shapes. In a further embodiment, the pre-madedenture set-ups may be made by creating designs of a variety of archshapes, sizes, and teeth alignments and orientations, and forming waxset-ups with denture teeth set in wax according to the particulardesigns. The wax set-ups may be cast as stone models from which imagedata of the models may be obtained. Images of the pre-made dentureset-ups may be taken, for example, by known scanning methods to formdigital data files of the denture set-ups. In one embodiment, forexample, the pre-made denture set-ups are scanned by a desktop scannerto form digital data files in a .dcm format, that can be converted, forexample, into an .stl format, to create virtual computer generated 3Drepresentations of the virtual denture teeth designs by known softwareprograms (such as 3Shape Dental Designer™). The method of scanningdenture set-ups may be by any known method of scanning, as describedherein, that is suitable for creating digital data files that can beconverted to virtual 3D representations.

in a further step, the virtual 3D representation of the multiplicity ofscanned denture set-ups can be modified by design software programs tooptimize the virtual denture teeth designs. In one embodiment, denturedesign software tools can be used to virtually remove scanned gingivalregions of the pre-made denture set-ups. Thus, in one embodiment, thevirtual gingiva regions from the pre-made denture set-ups are removedleaving only the virtual denture teeth set in a specific alignment andorientation. The resulting virtual 3D representations comprise aplurality of pre-designed virtual denture teeth designs (30) thatcomprises teeth sets (31, 32) prearranged in a fixed position in anocclusal scheme corresponding to an arch shape and size. By eliminatingscanned gingival regions of the pre-made denture set-ups, patientspecific data can be incorporated into the new virtual denture design toreplicate the patient's gingival architecture. Digital data files (509)of the virtual denture teeth designs may be added, for example, to avirtual library of existing dental restoration software that is suitablefor use in designing a virtual denture. In one embodiment, anon-transitory computer readable medium is provided having one or morecomputer instructions stored thereon, wherein the computer instructionscomprise instructions for execution on a computing system for carryingout a method of designing a plurality of virtual denture teeth designsas described herein.

In one embodiment, as exemplified in FIGS. 6a and 6b , upper and lowerportions of a virtual denture teeth design (61 and 67) are createdhaving a virtual teeth set (63) in a prearranged fixed positioncorresponding to the ovoid shape of an arch. In another embodiment, asillustrated in FIG. 7a , a pre-designed upper virtual denture teethdesign (71) is created having the virtual teeth set (73) prearranged ina fixed position corresponding to the tapering shape of an arch. In afurther embodiment, FIG. 8a illustrates a pre-designed upper virtualdenture teeth design (81) and virtual teeth set (83) that is prearrangedin a fixed position on a virtual ridge (82) corresponding to a squarearch shape. The virtual teeth sets may be pre-arranged in occlusalschemes according to additional arch shapes, as well as arch shapes thatcombine features of ovoid, square and tapering, such as a square-ovoidarch shape and a tapering-square arch shape.

In one embodiment, the computer executable instructions for formingvirtual denture teeth designs comprises instructions for selecting andapplying teeth from a digital library in a pre-arranged, fixed position,and arranging the virtual teeth in an occlusal scheme that correspondsto a shape of an arch selected from ovoid, tapering, and square. Inanother embodiment, the method for making a virtual denture teeth designcomprises obtaining digital data files of scanned pre-made dentureset-ups having teeth set in fixed positions in an occlusal schemecorresponding to a plurality of arch shapes, for example, ovoid,tapering and square; converting the digital data files into a virtual 3Drepresentations; and modifying the virtual 3D representations byremoving the virtual gingival regions to provide a virtual denture teethdesign.

In a further embodiment, to provide for enhanced aesthetics, virtualdenture teeth designs are created that have subtle differences in thealignment of teeth relative to each other, while still conforming to theoverall arch shape. Teeth arrangements, such as an ideal arrangement, amasculine arrangement, or a feminine arrangement, can be selected toachieve a look that is pleasing to the patient. A method for makingvirtual teeth designs is provided that comprises providing computerexecutable instructions for arranging teeth in an arrangement havingsubtle differences in the alignment of teeth relative to each other,while still conforming to the overall arch shape. In a furtherembodiment, a method comprises forming virtual denture teeth designs byselecting a plurality of pre-made dentures comprising subtle differencesin the alignment of teeth relative to each other, and formingpre-designed virtual denture teeth designs from the pre-made dentures asdescribed above.

With reference to FIGS. 6a, 6c and 6d , the virtual denture teethdesigns (61, 61′, and 61″), which are shown on virtual arches (62, 62′,and 62″), comprise an ovoid shape with the virtual teeth setpre-arranged in an ideal arrangement, a masculine arrangement, and/or afeminine, respectively. An ideal arrangement corresponding to an ovoidarch shape, as exemplified in FIG. 6a , may comprise upper centralincisors (64), lateral incisors (65), and cuspids (66) set to a fullcurve around the arch. In another embodiment with reference to FIG. 6c ,the virtual denture teeth design (61′) comprises an ovoid shape, whereinthe prearranged teeth set (63′) is aligned in a masculine arrangement. Amasculine arrangement of a teeth set may comprise central incisors (64′)that are wider than the teeth of an ideal arrangement, the masculinearrangement may comprise central incisors in a substantially lineararrangement, with outward rotation at the distal, and/or lateralincisors (65′) having a mesial rotation relative to the central incisors(64′). In another embodiment with reference to FIG. 6d , the virtualdenture design (61″) comprises an ovoid shape, with a virtual teeth set(63″) in a feminine arrangement. A feminine arrangement of the virtualteeth may comprise central incisors (64″) that are less wide than in anideal arrangement, in substantially linear arrangement or with a slightmesial rotation, and/or lateral incisors (65″) with an outward mesialrotation.

With reference to FIG. 7a , the virtual denture teeth design (71) thatis shown on a virtual arch (72), comprises a tapering shape. The virtualtooth set (73) is pre-arranged in an ideal arrangement. In an idealarrangement corresponding to a tapering arch shape, the central incisors(74), lateral incisors (75) and canines (76) may be arranged on an archhaving a curve that converges to a point midline between the centralincisors. In a further embodiment with reference

to FIG. 7b , the virtual denture teeth design (71′) comprises a taperingshape with the teeth set (73′) in a masculine arrangement, and may haveslightly larger central incisors (74′) or canines (76′). The lateralincisors (75′) may have a slight distal rotation. In a furtherembodiment with reference to the virtual denture teeth design (71″)shown in FIG. 7c , the virtual teeth set (73″) is in a femininearrangement, having lateral incisors (75″) with an outward mesialrotation.

With reference to FIG. 8a , the virtual denture teeth design (81) shownon a virtual arch (82) comprises a square shape, and the pre-positionedvirtual teeth set (83) is pre-arranged in an ideal arrangement. In anideal arrangement of a square arch shape, the central incisors (84)and/or the lateral incisors (85) may be substantially in lineararrangement. In a further embodiment with reference to FIG. 8b , thevirtual denture teeth design (81′) comprises a square shape, and virtualteeth set (83′) is in a masculine arrangement. The central incisors(84′) may be larger or squarer in shape than in an ideal arrangement,and the central incisors (84′) may be rotated outwardly at the distal,and the lateral incisors (85′) may be rotated inward relative to thecentral incisors (84′). In a further embodiment with reference to FIG.8c , the virtual denture teeth design (81″) comprises a square archshape, and virtual teeth (83″) are in a feminine arrangement. In afeminine arrangement, the teeth may have a slight distal rotation of thelateral incisors (85″) toward the distal.

In FIG. 9, a predesigned virtual denture teeth design, shown inocclusion on upper and lower virtual arches (93 and 94, respectively),is in a cross-bite configuration having upper (91) and lower (92) teethsets. In this embodiment, a lower virtual teeth set (92) is positionedin buccal version to the upper virtual teeth set (91) when upper andlower arches are in occlusion. In a further embodiment, as exemplifiedin FIG. 10, a pre-designed upper (101) and lower (102) virtual dentureteeth design is shown in a lingualized occlusion configuration on upperand lower virtual arches (103 and 104, respectively). In thisembodiment, in occlusion the lower virtual teeth set (102) is positionedlingually relative to the upper virtual teeth set (101).

With reference to FIG. 3, pre-designed virtual denture teeth designs(30) each comprise upper and lower teeth sets (31, 32), and may befurther designed to comprise a virtual gingival boundary line (33) thatis specific to each virtual denture teeth design. The computing systemmay comprise software having executable instructions for providing of anumber of virtual points (34) to be placed on the virtual teeth of thevirtual denture teeth design. The computer executable instructions ofthe software program are adapted to map a number of reference points(34) on the virtual teeth set and create a line (35) that intersects thepoints on adjacent teeth, forming the virtual gingiva boundary line. Inone embodiment, interproximal points (38) are located between teeth tofacilitate forming a continuous gingival boundary line that traversesadjacent teeth, and upon execution of computer instructions, forms avirtual gingiva that, for example, extends over the interproximal spaceof the teeth, and/or or forms virtual interdental papillae. In oneembodiment, the executable instructions are adapted to locate multiplepoints on the virtual teeth set and intersect the points to form avirtual gingiva boundary line that traverses the interproximal space ofadjacent teeth, and that is continuous throughout the entire virtual setof teeth, in a single step. The virtual gingiva boundary lineestablishes a region where virtual gingiva will be automaticallygenerated via executable computer instructions when integrated with thedigital data of the patient's oral anatomy, without having to manuallydraw a virtual gingiva line on individual teeth, or each set of teethevery time a virtual denture is created. In one embodiment, thegenerated gingival boundary line continuously traverses substantiallyall of the teeth of the virtual denture teeth design. In anotherembodiment the gingival boundary line is on at least a portion of theteeth of the virtual set. In another embodiment, the virtual gingivalboundary line continuously traverses multiple teeth, such as the teethof the anterior teeth region (36), the posterior teeth region (37), aportion of the anterior teeth region, or a portion of the posteriorteeth region, and generates a virtual gingiva that incorporates patientspecific gingival architecture.

As mentioned above, the plurality of virtual denture teeth designs hasmultiple sizes of the same arch shapes to accommodate the needs ofmultiple patients having a variety of arch sizes. The multiplicity ofsizes accommodate differences in molar-to-molar distances,canine-to-canine distances, vertical dimensions of occlusion, and/ormeasurements of front to back distances (as measured, for example, asthe distance between the incisive papillae in the front and a centralpoint between molars in the back of the mouth). To accommodatedifferences in arch sizes, a plurality of virtual denture teeth designsmay be pre-designed with teeth having a selected width that is suitableto accommodate a specific arch size. To accommodate differences invertical dimension of occlusion (VDO), a plurality of virtual upper andlower denture teeth designs may be created by selecting teeth having alength suitable to accommodate a specific VDO.

The virtual denture teeth design as described herein, may be created bydeveloping computer executable instructions for selecting virtual teethhaving a specific size and shape, and for arranging virtual teeth intothe designs, or by use of a known software program for designing dentalrestorations. Once formed, the designs may be saved in athree-dimensional digital data file format, such as .stl. The virtualteeth sets may be designed by selecting teeth having a specific toothsize and shape from a digital library of a computer software program fordesigning dental restorations, or from a known manufacturer of dentureteeth. Where the virtual denture teeth designs are created by selectionof pre-made denture set-ups in a variety of sizes, the virtual dentureteeth set correspond to the specific denture teeth size and shape thatwas selected when the pre-made denture set-ups were originally formed.Denture teeth are constructed having a specific size, form, shape, andcolor. Each tooth may be indicated by a mold number providingconsistency in size and form, and therefore virtual denture teethdesigns may comprise teeth corresponding to specific mold numbers asprovided for by the denture teeth manufacturer, such as Kenson® dentureteeth (distributed by Myerson LLC, Chicago, Ill.) or VITA Vident®denture teeth (Vident, Brea, Calif.). Virtual denture teeth designs areshown with teeth characteristics such as pits (69).

The virtual denture teeth designs may comprise posterior and anteriorteeth, and may comprise a complete set of virtual teeth required for afinal denture. Anterior teeth and anterior teeth region refers to theteeth in the front of the mouth, specifically the central incisors,lateral incisors, and cuspids (canines) of the maxillae and mandible.Posterior teeth and posterior teeth regions refer to the teeth that areposterior to the anterior teeth on the maxillae and mandible, forexample, the first bicuspids, second bicuspids, first molars, and secondmolars.

In designing a plurality of virtual denture teeth designs, previouslymade actual dentures were analyzed and compared to patient data to forma plurality of designs that would accommodate a multiplicity of patientcases without requiring individual positioning or adjustment of separateteeth.

Virtual Denture

Observations and/or measurements from the patient's oral anatomy, aswell as the patient's gender, are useful to select an appropriatepre-designed virtual denture teeth design from among the plurality ofpre-made designs. Measurements of patient data are taken to select thevirtual denture teeth design that has the greatest correspondence inarch size and arch shape, and bite relationship, from the plurality ofvirtual denture teeth designs. Patient data may be obtained, forexample, from an actual or scanned impression, stone model, or existingdentures, or a scan of the patient's mouth, and include measurementsthat are typically obtained in traditional denture manufacturingprocesses. Patient information useful in selecting a virtual dentureteeth design include measurements of a patient's edentulous ridge, forexample, the molar-to-molar distance (e.g., the distance between secondmolars) of the mandible when measured straight across the arch, andsimilarly the distance between maxillary tuberosity of the maxillae,canine-to-canine distance, distance between incisive papilla and thecenter line between the molars, and the vertical dimension of occlusionof the mandible and maxillae. In one embodiment, the selection of avisual denture teeth design may be based on the measurement of maxillarytuberosity distance of the upper edentulous ridge of a patient and thevertical dimension of occlusion.

A screen shot from a display unit, displaying an image and tools from asoftware program used for forming a virtual denture is illustrated inFIG. 11. A screen shot depicts an image of a 3D representation (112) ofa scan of a stone model of a patient's oral anatomy, stored as a digitalfile on a computer system memory device. When the image is shown on thedisplay unit, a gingiva region may be created over the areacorresponding to the virtual arch, using tools of a software program. Avirtual denture teeth design (113) stored as a digital file in a designlibrary in a memory device is also shown. The virtual denture teethdesign (113) may be selected from a plurality of designs (116) throughuser interface tools usable by execution of instructions provided by asoftware program. The 3D representation of the patient's oral anatomyand the virtual denture teeth designs may be aligned, for example, by aknown dental restoration software program having executable instructionsfor transferring digital patient data to a virtual dental restoration.CAD dental restoration software, such as the software program used forvirtual dental restorations may be used to apply and align the virtualdenture teeth design (113) to the patient's ridges shown on the stonemodel (112). Each virtual denture teeth design comprises upper and lowerregions (114, 115) in fixed occlusion, that move as a single unit. Asoftware program having tools functioning through executableinstructions may be used to rotate the virtual denture teeth design ifnecessary to provide appropriate alignment with the virtualrepresentation of the patient's upper and/or lower ridges (112, 112).Where the virtual teeth set (113) is preconfigured in a fixed positioncorresponding to the shape of an arch, all of the teeth (117) of boththe upper and lower portions of the virtual denture teeth design (113)move in unison, and rotation of the virtual denture teeth design doesnot result in independent movement or rotation of individual virtualteeth (113).

In one embodiment, where the pre-designed virtual denture teeth setcomprises a pre-designed virtual gingival boundary line (FIG. 3, at 35),a set of computer executable instructs is applied to automaticallycreate a gingiva that extends between the virtual denture teeth designand the 3D representation of the patient. Population of a gingiva thatextends from the virtual denture design to the 3D representation of thepatient may be performed in one step. A set of executable instructionsfrom a software program may be used, for example, to modify virtualouter and inner gingival surfaces, and/or to add root eminence by theuse of a mouse through a user interface. The virtual denture may furthercomprise a virtual base region that is adapted to conform to the 3Drepresentation of the patient's palate and edentulous ridge. The virtualbase region may comprise virtual hard and soft palate regions and/or aregion designed to correspond to the maxillae and/or mandible of thepatient.

Information relating to the virtual denture may be recorded. A digitaldata file of the virtual denture may be created and stored, for example,on a memory device of the computer system, which can then be accessibleto the automated manufacturing system by a network interface. In oneembodiment, the digital data file of the virtual denture may betransferred to a separate computer system and software program suitablefor use in an automated manufacturing process.

In one embodiment, a non-transitory computer readable medium is providedhaving one or more computer instructions stored thereon, wherein thecomputer instructions comprise instructions for carrying out a method ofdesigning a virtual denture by transferring at least a portion of adigital representation of patient scan data to the virtual denture teethdesign. The methods described may be implemented via software run on acomputing or processing system executing the computer instructions. Thecomputer instructions may be provided by a program code or codeslocated, for example, on a computer memory, or accessible through acomputer network, such as a local network. Thus, a method is describedcomprising a computer implemented method of designing a virtual denturecomprising selecting a virtual denture teeth design from a plurality ofdesigns, wherein the virtual denture teeth design comprises a teeth setthat is prearranged in a fixed position in an occlusal schemecorresponding to an arch shape and size; virtually applying the designto a virtual 3D representation of a patient's oral anatomy; virtuallyaligning the design and the virtual 3D representation of the patient'soral anatomy; and virtually applying a virtual gingival boundary line ofthe virtual denture teeth design to form a virtual gingiva between thevirtual denture teeth design and the 3D representation of the patient'soral anatomy to generate a virtual denture.

Automated Manufacturing Processes

Advantageously automated systems (508) may be used to form a physicalmodel of a denture device from a virtual denture. The resulting physicalmodel may have detailed characteristics of the patient's oral anatomy,as obtained from the digital data. Additive manufacturing processes,such as 3D printing, can quickly form a physical model from a virtualdenture. Subtractive manufacturing processes, such as milling may alsobe used to form the physical model from the virtual denture. Gingivalfeatures and palatal contours unique to the patient may be faithfullyreplicated from the virtual denture. A physical model of a virtualdenture formed with the patient's unique characteristics have a customfit since the characteristic features of the soft tissue are importantto providing a secure fit.

FIG. 12 illustrates a physical model (120) of a virtual denture havingupper and lower portions that fit on the upper and lower edentulousridges of a patient, constructed by the methods described herein. In oneembodiment, the physical model is a 3D printed denture (120) havingprinted features replicating the virtual denture features of the upperand lower virtual arches, anterior and posterior teeth regions, andsurrounding gingival regions. In one embodiment, the 3D printed denturecomprises a printed upper portion (121) having a printed base that fitssecurely to the palate and maxillae of a patient, and a printed lowerportion (122) having a printed base that fits securely onto the mandibleof the patient. The physical model further comprises printed anterior(124) and posterior (125) regions, corresponding to the printed anteriorand posterior teeth regions and printed anterior and posterior gingivalregions. Additionally, the physical model comprises inner (126) andouter (127) gingival regions, a ridge region (128) between teeth regionsand gingival regions, and a printed palate region (129).

In one embodiment, the automated manufacturing process is a 3D printingprocess, and a 3D printer may be connected directly to a computer system(500) used to design the virtual denture, or it may be connected to aremote computer by a network interface (510) that receives a data filefor the virtual denture. 3D printing systems capable of converting thevirtual denture to a physical model are suitable for use herein.Suitable printing devices include but are not limited to printers basedon masking technology, continuous jet stream printers and drop-on demandstream printers. For example, both a raster and vector type apparatuscan be used. A raster apparatus may comprise multiple print heads thatmoves back and forth across a layer. A vector apparatus may use onenozzle to draw the entire cross-section. Examples of suitable 3Dprinting devices include 3D printers manufactured by 3D Systems(Valencia, Calif.) and Stratasys (Minneapolis, Minn.)

In one embodiment, an automated manufacturing system (508) comprises a3D printing system which can be used with the methods described. The 3Dprinting system may comprise a computing device, a 3D printer having aprinter controller and a 3D print head module. The 3D printer can be anysuitable 3D printing machine that is capable of forming a 3D physicalmodel of the virtual denture that is suitable for use as a functionalfitting replica denture. The 3D printer may include a buffer memory forreceiving a print file in the form of signals from the computing device,an image buffer for storing printing data, and a printer controller thatcontrols the overall operation of the 3D printer. The printer controllermay control, for example, one or more printer drivers for driving the 3Dprint head module and associated transport mechanisms. A data store(local memory) and a display unit for setting the parameters of theprinter may also be included.

Suitable computing systems may include personal computers such as thosehaving Pentium IV microprocessors supplied by Intel Corp. USA withmemory and graphical interface such as Windows 98, 2000, ME, XP(Microsoft Corp. USA). A computing system may include a microprocessorand associated memory for storing or buffering source images,intermediate arrays of data and calculations as well as the print files.Examples include volatile random access memory (RAM), non-volatileread/write memory such as a hard disc as well as non-volatile read onlymemory (ROM).

A computer program software product providing a printing method forprinting the 3D representation of the virtual denture is executed on thecomputing device. In one embodiment, the computer program may be storedon a data carrier such as a CD-ROM or diskette, storing the computerprogram in a machine readable form that is capable of executing aprinting method. In another embodiment, a computer program softwareproduct may be provided via the internet or a company intranet fordownload to the computing device transmitting the computer programsoftware product over a local or wide area network.

various materials may be used for forming the 3D physical model of thevirtual denture. Polymeric materials suitable for use herein include butare not limited to polyamides, polyesters, polyolefins, polyimides,polyacrylates, polyurethanes, vinyl esters, or epoxy-based materials.Other polymeric materials include styrenes, styrene acrylonitriles,acrylonitrile butadiene styrene (ABS) polymers, polysulfones,polyacetals, polycarbonates, polyphenylene sulfides and the like. In oneembodiment, polymeric materials include those based on acrylic andmethacrylic monomers. In another embodiment, polymers suitable for useherein include but are not limited to acrylonitrile butadiene styrene(ABS), polycarbonate (PC), polylactic acid (PLA), high densitypolyethylene (HDPE), PC/ABS, and polyphenylsulfone (PPSU).

The physical model of the virtual denture (120) is constructed to fitsecurely into the mouth of the patient with little or no finishing.Where the physical model is printed to correspond with the virtualdenture that has been designed with patient-specific data, it conformsto the contours of a patient's oral anatomy and fits securely on thepatient's edentulous ridge.

Forming a Mold of the Physical Model

After formation of a physical model by an automated manufacturingprocess, the physical model may be modified by adding actual dentureteeth to form the functional fitting replica denture. In one embodiment,a method comprises an automated process of setting denture teeth, andforming a gingival architecture that replicates the virtual denturedesign. In this process, inconsistencies and inaccuracy that occurthrough known manual, or ‘by-hand’, waxing and setting processes can beavoided.

To provide a location in which to incorporate actual denture teeth inthe physical model, at least a portion of the material of the physicalmodel may be removed. In one embodiment, substantially all of thematerial that corresponds to the anterior and posterior teeth regions ofthe physical model is removed. In another embodiment, only a portion ofthe teeth regions of the physical model is removed. In a furtherembodiment, a gap is formed in a portion of the physical model toprovide a space for the denture teeth.

To ensure that the placement of the actual denture teeth replicates theorientation and occlusal scheme of the virtual denture and the physicalmodel, in one embodiment, a mold of the physical model is formed priorto removing material from the physical model. The mold replicatesdetails of the region of the physical model in which the denture teethwill be located. Thus, in one embodiment the mold captures the exactposition, size, occlusal scheme, and alignment of the teeth asprescribed by the virtual denture design. Further, the mold may providea guide for positioning actual denture teeth on the physical model byautomatically recreating the teeth position and occlusal scheme.Moreover, the mold may replicate the gingival architecture that has beencreated in the physical model. By gingival architecture, it is meant thesoft tissue characteristics, features and details of the inner and outergingival regions, anterior and posterior gingival regions, and/or palateregions of the patient that have been provided by the patient data andreplicated in the virtual denture and physical model. The gingivalarchitecture can be formed in the functional fitting replica denture byuse of the mold, in a reproducible manner according to the virtualdenture design. The mold may be made by any known processes for makingmolds or impressions in dental restoration, and the mold may be made ofthe entire physical model of the denture or a portion of the physicalmodel. The mold may be formed from stone, alginate, silicone, rubber,and the like.

In one embodiment, with reference to FIGS. 13a and 13b , a mold is madeof the anterior teeth region, a portion of the posterior teeth regions,and the surrounding gingival regions of an upper portion of a physicalmodel (131) and a lower portion of a physical model (131′) by pressing aformable material (130, 130′) on the regions. A mold may be taken of theentire teeth region of the printed model, or only a portion of theanterior and posterior teeth regions. FIGS. 13a and 13b , illustrate anexample of a mold wherein the second molars (132, 132′) are notincorporated into the mold. In a further embodiment, a moldable materialis pressed onto the palate of a physical model. When sufficientlyhardened to remove without compromising the impressed details, thehardened moldable material is removed to form a mold. A method formaking the mold of the anterior region of the 3D printed dentureincludes applying a moldable material on a portion of the 3D printedphysical model that corresponds to anterior teeth region correspondingto cuspids, central incisors and lateral incisors, and gingivalstructures surrounding the anterior teeth. In another embodiment, theformable material is applied to anterior and posterior teeth regionscorresponding to the central incisors, lateral incisors, cuspids(canines), first bicuspid (first premolar), and second bicuspid (secondpremolar), and a portion of the gingival regions surrounding the teethincorporated in the mold. In a further embodiment, a mold may be formedthat further comprises an impression of the first molar and optionally,the second molar, as well.

A mold comprises a relief of the characteristics and features thephysical model of the virtual denture, such as the arch shape and sizecorresponding to the virtual denture. The mold further comprisesrecesses into which actual denture teeth are set, wherein the recesseshave an orientation, size and shape corresponding to the virtual dentureteeth, and the recesses are in the fixed prearranged positioncorresponding to the arch shape. The mold may further have an impressionof at least a portion of the surrounding upper and or lower gingivalregions, comprising gingival details and palatal characteristics presenton the 3D printed denture.

Any method suitable for obtaining a dental impression, including forexample, methods used to obtain an impression from a patient's oralanatomy in preparation of a restoration may be used to form the mold.Suitable materials for making the mold include sodium alginate,hydrocolloid, polyether and silicones including condensation curedsilicones and addition-cured silicones, including polyvinyl siloxane(PVS).

Forming the Functional Fitting Replica Denture

At least a portion of the physical model may be removed for placement ofthe denture teeth. Any suitable technique for removing material may beused, such as a variable speed grinding hand-piece and bur, known foruse in dental laboratories for finishing and/or detail work. Uponremoval of the teeth region from the physical model, a ridge may beformed that bridges the inner and outer gingival regions.

In one embodiment, exemplified in FIG. 14, a portion of the physicalmodel that corresponds to an anterior upper and/or lower teeth region(143, 143′) and an upper and/or lower gingival region is removed, forexample, by cutting out or grinding away the material. Upon removal ofthe anterior teeth region(s), an upper ridge (144) and/or a lower ridge(144′) may be formed in the physical model. The ridges may bridge innerand outer gingival regions. In one embodiment, a ridge (144 and 144′) isformed that is substantially parallel to the occlusal plane. The ridgemay be substantially flat or planar, so that the ridge of the physicalmodel (143) has no alveolar sockets or slots in which to set dentureteeth. A sufficient amount of the physical model is removed to provide adistance between the ridge and occlusal plane enabling the actualdenture teeth to be set in the gap (142) according to the design of thevirtual denture, while maintaining the desired bite relationship.

In a further embodiment, an additional amount of the material of thephysical model is removed corresponding to the anterior gingival regionto form a gingiva indentation (145, 145′) adjacent to the gap in thephysical model. The gingiva indentation borders the gap and extends to afinish line (146, 146′). The gingiva indentation may be present in boththe upper and lower gingival regions, and the gingiva indentation mayborder a part of the gap or it may border the entire gap The gingivaindentation provides an area within which to replicate the patient'sgingival architecture in a formable material according to the virtualdenture while maintaining the dimensions of the printed physical model.

All or a portion of actual denture teeth that correspond with thevirtual teeth set of the virtual denture design may be obtained forplacement on the physical model. Denture teeth may comprise an acrylicmaterial or any other material suitable for use as denture teeth. Themold (130) of the physical model may serve as a guide for positioningdenture teeth in relation to the physical model. In one embodiment, toincorporate the denture teeth into the physical model, the mold havingteeth set in the mold recesses and the physical model may be assembled,positioning the denture teeth, for example, in a gap (142). Formablematerial may be introduced into the mold to set the teeth in place inthe gap. In one embodiment, the mold is injected and filled with aformable material, e.g., through injection channels in the mold. Aportion of each of the denture teeth may be embedded in the formablematerial to hold them in place in the gap. The mold and the physicalmodel may be disassembled after the formable material is hardened,revealing the functional fitting replica denture.

Thus, in one embodiment, a method for making a functional fittingreplica denture is described comprising the following steps as outlinedin FIG. 15: obtaining a physical model of a denture (151), optionallymade by a rapid manufacturing process; forming a mold of at least aportion of the physical model (152); removing a portion of a physicalmodel (for example, that corresponds to an anterior teeth region) toform a gap and a ridge (153); selecting a plurality of actual dentureteeth (154); positioning the denture teeth in the mold (155); assemblingthe mold and the physical model (156), using a mold of the physicalmodel to form a guide for placement of denture teeth in position in thegap of the physical model; and introducing a formable material in themold (157), to hold the actual denture teeth in position in the gap ofthe physical model, adjacent the ridge; and separating the mold and thephysical model (158), creating a functional fitting replica denture.

A functional fitting replica denture, as illustrated in FIG. 2,comprises an upper part (21) and a lower part (22), each having a base(20) with an inner shape that fits securely on the maxillae and mandibleof an edentulous patient. Actual denture teeth (23), shown with teethdetails (29) on the occlusal surface, are embedded in formable material(24) that fills the gap (FIG. 14, at 142) of the physical model (28). Inone embodiment, a portion of the denture teeth corresponding to thecrown (25) is exposed, (i.e., not embedded in the formable material),and a portion corresponding to a neck (26) of the tooth may be embeddedin the formable material. The formable material (24) fills the gap andabuts the ridge of the gap. The denture teeth may be adjacent the ridgeof the physical model and may be held in place by the formable material.

In a further embodiment, a functional fitting replica denture is formedthat comprises a first portion comprising a physical model of a denturethat fits securely in the mouth of a patient that comprises a firstmaterial. The first portion comprises first and second posterior teethregions, a gap between the posterior teeth regions that corresponds toan anterior teeth region; an anterior gingival region adjacent the gap;and a ridge between the posterior teeth regions adjacent an anteriorgingival region. The functional fitting replica denture furthercomprises a second portion, comprising a second material, discrete fromthe physical model of the denture that at least partially fills the gapand holds a plurality of denture teeth (23) in position. In oneembodiment, the ridge is substantially flat, and the denture teeth areadjacent the flat ridge. In one embodiment, a functional fitting replicadenture is formed wherein the denture teeth positioned in the gap of thephysical model of the denture are anterior denture teeth; in oneembodiment the denture teeth comprise six of the upper anterior mostteeth, including the central incisors, lateral incisors, and cuspids. Ina further embodiment, a functional fitting replica denture is formedwherein the denture teeth positioned in the gap of the physical model ofthe denture comprise six upper teeth and six lower teeth, including fourcentral incisors, four lateral incisors and four cuspids.

In one embodiment comprising a gingiva indentation in the gingivalregions of the physical model, formable material (24) fills the gingivaindentation, and tapers to the finish line (27) of the physical modelproviding a gingival architecture comprising the formable material. Theportion of the gingival architecture constructed from the formablematerial does not add to the thickness of the physical model. Thus,maintaining the dimensions and proportions of the patient's gingivalarchitecture. The gingival architecture replicates the patient's oralanatomy that was incorporated into the virtual denture design. Thegingival architecture made from the formable material has a size andstructure corresponding to the patient's information, and thereforeconforms to the patient's oral anatomy providing a precisepatient-specific fit. Where the process for making the gingivalarchitecture is automated by use of a mold, and incorporates patientdata, the process is standardized when compared to traditional wax-upprocess, making the gingival architecture consistently reproducible.Thus, whereas traditional manual waxing does not replicate the patient'sspecific fit and characteristics, the automated process creates agingival architecture made from formable material that replicates thepatient's gingival structures.

Formable materials suitable for use herein include, for example,flowable composite materials, hydroplastic materials, and thermoplasticmaterials. In one embodiment, the formable material is a wax. Formablematerial may be material that can be softened again, for example, byheat, after hardening. In one embodiment, where it is determined that amodification of the position of the teeth or of gingival region isrequired or desired the formable material may be softened forre-positioning of the denture teeth. The formable material is introducedinto the cavity by any known techniques, for example, by injectionmolding a formable material by machine or syringe.

In one embodiment, the functional fitting replica denture comprises afirst material comprising the printed material, a second materialcomprising the formable material such as a wax, and a third materialthat is used for making the denture teeth that is different from thefirst and second material. The first material may be a substantiallyrigid, that will not deform when inserted into the mouth of a patientfor evaluation. The second material holds the denture teeth in place,and is a formable or substantially formable material, includingthermoformable materials and thermoplastic materials such as wax. Theformable material may allow the teeth to be set in place for try-in andbe readily movable by a dentist or laboratory technician.

Where the functional fitting replica denture comprises both a firstportion corresponding to the physical model and a second portioncorresponding to the formable material made from the mold, and whereboth incorporate information of the patient's oral anatomy, thefunctional fitting replica denture fits securely in the mouth of thepatient. The functional fitting replica denture and any modifications tothe functional fitting replica denture may be scanned, recorded andstored, for example, as digital files, that can be reproduced. Moreover,the virtual denture files may be modified based on any modifications tothe functional fitting replica denture after evaluation by the patientand dentist. The modified virtual denture files may be recorded, savedas a digital file, and stored. In one embodiment, upon loss ordestruction of the final denture, the digital file of the virtualdenture may be retrieved and a new physical model of the denture can becreated, for example by an automated manufacturing process.

In a further embodiment, a method is described for making a partialdenture for a partially edentulous patient that comprises method stepsthat were used in making a full denture. A partially edentulous patienthas at least one edentulous ridge region for which a partial denturerestoration is desired. Digital data of the patient's oral anatomy isobtained that comprises information about the edentulous ridge region(s)and surrounding teeth and/or gingiva regions. The digital data file maybe converted into a 3D representation of the patient's oral anatomy, ina format that is compatible with a dental software restoration programfor designing a virtual partial denture. Virtual denture teeth designsmay be created that are suitable for use in partial dental restorations,and may be stored, for example, on a local or remote memory. In oneembodiment, a plurality of virtual denture teeth designs may be createdthat are suitable for a multiplicity or a majority of patients in needof a partial denture restoration. The virtual partial denture may beprepared by known software programs that apply and align a patient'sdigital data information with a digital virtual denture design, in amanner described above, for the virtual denture. Patient data may betransferred via execution of design software instructions to the virtualdenture teeth design, to incorporate patient specific data regardingexisting dentition, gingiva and palatal characteristics, biterelationship data, and the like, to form the virtual partial denture.

In another embodiment, dental design software programs may be used tomodify a digital data file of a partially edentulous patient byincorporating virtual teeth that are provided as part of a remote orlocal library, as described above. A digital file of the virtual partialdenture may be provided in a format compatible with an automatedmanufacturing system, such as those described herein (for example, a 3Dprinting process). In one embodiment, after formation of a virtualpartial denture, a partial physical model may be made, for example, byan additive manufacturing process, or a subtractive process. In oneembodiment, a mold is formed of at least a portion of the physicalpartial denture model that corresponds to one or more edentulous ridgeregions where replacement or denture teeth will be located, for example,one or more teeth from the posterior or anterior teeth regions. In afurther embodiment, the mold is formed of the ridge regions wherereplacement or denture teeth will be located, and, still further, themold may include impressions of additional teeth or gingiva on each sideof the tooth or teeth to be replaced. After formation of a moldaccording to processes described herein, one or more portions of thephysical model may be removed to form a gap, a ridge, a gingivaindentation of the gingival regions, and/or a finish line, in a regionor regions that correspond to the location of replacement or dentureteeth. Denture teeth may be set in the mold which is used to guide theteeth into position adjacent the ridge of the gingival region. Aformable material is introduced into the mold to set the denture teethin place in the physical model of the partial denture in a positioncorresponding to the virtual partial denture, for example, by injectionthe formable material. Upon completion and evaluation of the functionalfitting replica denture, a final partial denture may be formed usingprocesses described herein, or those known in the art for processingdentures and partial dentures.

In a further embodiment, it may be desirable to wear a denture designfor an extended or long term trial period prior to forming a finaldenture. Thus, in one embodiment, the physical model of the denture maybe worn prior to forming a functional fitting replica denture, orinstead of forming the functional fitting replica denture. In thismanner, the patient may have an extended opportunity to wear thephysical model to check for bite relationship while biting and chewing,and/or to allow the patient an extended opportunity to check theappearance of the physical model outside of the dentist's office. In oneembodiment, a portion of the thickness of the gingival region of thephysical model is reduced, while leaving the teeth regions of thephysical model intact. In one embodiment, a portion of the physicalmodel that corresponds with the anterior gingival region is reduced bygrinding with a handpiece, thereby providing an anterior gingivalindentation surrounding the anterior teeth regions (for example, teethregions corresponding to the central and lateral incisors, and cuspids).Formable material, such as a colored wax (e.g. a color matching thepatient's actual gingiva), may be introduced in the gingival indentationto provide a patient with a realistic appearance of the final denture.The formable may be introduced into the gingival indentation by hand.Alternatively, formable material may be introduced via a mold of thegingival region as described above. In one embodiment, a methodcomprises obtaining a physical model of a virtual denture of a patient,obtaining a mold of a gingival region of the physical model, removing aportion of the gingival region surrounding the teeth, assembling themold and the physical model, and introducing a formable material intothe mold to form a physical model comprising a gingival architecturecomprising formable material that replicates the patient information.Because a large portion of the physical model remains intact, theresulting modified physical model may be suitable for a long term use.

Device for Determining the Vertical Dimension of Occlusion

To evaluate proper position of the teeth and to determine the positionalrelationship between upper and lower denture teeth, a device to registerthe bite of a patient may be used. In one embodiment, exemplified inFIG. 4, an apparatus for determining the vertical dimension of occlusion(40) is provided that comprises an upper functional fitting replicadenture (41) formed by the processes described herein, and a lowerocclusal recording device (42). They may be used together by insertioninto a patient's mouth, for purposes of evaluating and determining thevertical dimensions of occlusion in an edentulous patient by a dentist.Because the upper functional fitting replica denture (40) comprises abase (43) portion having an inner shape that fits securely to thepatient's palate and maxillae, an accurate bite relationship may beestablished by a dentist, increasing the accuracy of the fit, providinga better bite, and reducing likelihood that the final denture will bereturned to the dental lab for adjustments. Advantageously, the numberof visits required by the patient can be reduced wherein both theevaluation of the functional fitting replica denture and evaluation ofbite relationship may occur in the same visit. Traditionally, evaluationof a try-in denture was conducted in a first visit, followed by a secondvisit for evaluation of bite registration.

In one embodiment, an apparatus for determining the vertical dimensionof occlusion in an edentulous patient comprises 1) an upper functionalfitting replica denture comprising a physical model made from anautomated manufacturing process and anterior denture teeth embedded in aformable material that substantially fills a gap in the physical model,and 2) a lower deformable occlusal recording device. In one embodiment,an apparatus (40) for determining the vertical dimension of occlusioncomprises a first part that comprises an upper functional fittingreplica denture (41) as described herein, that fits securely on themaxillae of the patient. The first part comprises a first materialportion (44) having a gap that corresponds to at least a portion of ananterior teeth region and a ridge adjacent an anterior gingival region.The first part of the apparatus further comprises a second material(47), different and/or discrete from the first material, at leastpartially filling the gap in the first portion and abutting the ridge(48; not readily observable through the second material, as depicted bythe dashed line), and extending to the finish line (46); and a pluralityof anterior denture teeth (45), each tooth comprises a portion that isembedded in the second material. The second part of the apparatuscomprises a lower occlusal recording device (42) comprising a deformablematerial, such as a wax, dental rubber, or silicone. Data obtained fromthe occlusal recording device may be scanned and recorded, and used inthe process of forming a denture device.

Processing a Final Denture

The final denture comprising the actual denture teeth may be made by anymethod known in the art for processing a final denture from a functionalfitting replica denture. For example, an impression is taken of thefunctional fitting replica denture by setting it into an impressionmaterial, such as hydrocolloid. Upon solidification of the colloidal,the formable material of the functional fitting replica denture may beremoved, for example, by melting the material and pouring it out,leaving denture teeth in the designed position within the impression.The physical model portion of the functional fitting replica denture isalso removed, and any additional actual denture teeth needed for thefinal denture, that correspond to the virtual denture, are placed withinrecesses left by the physical model portion of the functional fittingreplica denture. A material suitable for forming the gingival portion ofa denture, such as acrylic, is poured, and a final denture having actualdenture teeth is formed.

The processes for making the final denture according to methodsdescribed herein advantageously reduce processing time over traditionaldenture processes. The final dentures produced by these methodssubstantially conform to the oral anatomy of the patient. Whilepolishing may be desired, removal or addition of significant materialmay not be necessary since the final denture corresponds to theappropriate thickness of the virtual denture, the physical model and thefunctional fitting replica denture. In contrast, traditionaldenture-making processes frequently require the addition or eliminationof denture material to achieve uniform thickness and a fit thatcorresponds to the patient's oral anatomy, as well as trimming, grindingand polishing. Where traditional processes result in removing materialto obtain a uniform thickness, loss of features such as root eminenceresults; therefore, additional finishing may be required toreincorporate features lost in the grinding process of traditionaldenture processes. The methods described herein advantageously reducethese limitations.

With reference to FIG. 16, a method of making a denture device isprovided that comprises the steps of: creating a digital library ofvirtual denture teeth designs (160); obtaining a virtualthree-dimensional (3D) representation of a patient's oral anatomy (161);selecting a virtual denture teeth design (162) having a virtual teethset prearranged in a fixed position in an occlusal scheme correspondingto a specific arch shape; applying the virtual dental teeth design tothe virtual three-dimensional representation of the patient's oralanatomy (163); aligning the virtual denture teeth design and the virtualthree-dimensional representation to generate a virtual denture (164);sending the digital data file of the virtual denture to an automatedmanufacturing system (165); and manufacturing a 3D physical model of thevirtual denture (166). In one embodiment, the final denture may beproduced directly from the physical model of the virtual denture (172).In a further embodiment, a functional fitting replica denture may beformed (169) prior to manufacturing the final denture (172) by forming amold of the physical model (167) and modifying the physical model byremoving a portion of it to incorporate actual denture teeth (168) inthe mold, assemble the mold and physical model, and introduce a materialto set the teeth in place, to form the functional fitting replicadenture (169). The method may further comprise forming an occlusaldevice (170) from the functional fitting replica denture and adeformable lower portion, which can be used for evaluation (171) priorto processing the final denture (172).

Method steps recited may be performed in any order in order to arrive ata denture device; thus, no particular order is implied or required wherethe ordering of steps is unnecessary to arrive at a particular device.The final denture has high precision with regard to fit and orientationadvantageously reducing the likelihood that the denture will be returnedby a patient for improper fit. Moreover, because the final denture isformed from an impression of, for example, a 3D printed denture, thefinal denture requires less material to be removed and fewermodifications. Processing of a final denture made according to themethods described herein require only slight modifications such assmoothing surfaces.

EXAMPLES Example 1

A plurality of virtual denture teeth designs were formed, each designhaving a teeth set prearranged in a fixed position in an orientationcorresponding to a fixed arch shape, and having a virtual gingivalboundary line.

A plurality of wax denture set-ups was prepared as follows. Data frommultiple patients were obtained for arch shape, bite relationship, teethalignment and orientation. Additionally, patient measurement data wereobtained for molar-to-molar distance (i.e., the distance between secondmolars) of the mandible and maxillae, as well as canine-to-caninedistance; both distances were measured straight across the arch.Measuring from the front of the arch to the back of the arch, thedistance between incisive papilla and the center point between thesecond molars was obtained. Further, the vertical dimension of occlusionof the mandible and maxillae was obtained from patient data. The datawere obtained from patient records, stone models, and/or final denturesthat were previously prepared by traditional denture manufacturingtechniques. From an analysis of the data, a multiplicity of designs werecreated to accommodate the measurements, arch shapes, and teethalignments of a majority of patients. Designs were created havingseveral arch shapes, including square, tapering, and ovoid. The designswere also specific to teeth size, such as teeth widths and lengths toaccommodate a variety of arch sizes, variations in vertical dimensionsof occlusions, and preferences in teeth shape, such as square, ovoid ortapering. The designs were created having teeth set in specificalignment around an arch, such as an ideal alignment, femininealignment, or masculine alignment. Further, designs were created forlingualized and cross-bite occlusion, in several arch sizes.

Each design comprised an upper and lower portion, corresponding to anupper and lower arch. Each design was prepared as a wax set-up, creatinga plurality of wax set-ups in various arch sizes and arch shapes. Waxset-ups were formed by shaping wax into a particular arch shape to forma wax rim. Actual denture teeth (Kenson® denture teeth) of appropriatesize and shape to correspond with a particular design were positionedaround a wax rim. Wax rims corresponding to upper wax set-ups werefurther adjusted by aligning teeth in ideal, masculine or femininearrangements. The lower portion of the wax set-ups was prepared in idealarrangements.

When finished, an impression was taken of each wax set-up, and stonemodels were formed of the upper and lower portions for each design. Theimpressions and stone models were prepared by standard denture makingtechniques for forming impressions and stone models. The stone modelscomprising an upper and lower portion were scanned using a 3Shapedesktop scanner to create a digital data file for each design in .dcmformat. The digital data file was exported into an .stl file to create avirtual 3D representation of each stone model for use with 3 Shapesoftware.

Using design software programs, instructions were executed on a computersystem to design a plurality of virtual denture teeth designs from thevirtual 3D representation of the stone models. The virtual stone modelswere trimmed using software cutting tools to remove substantially allfeatures of the stone model, such as the base, leaving the virtual teethsets. User interfaces provided for design control via a display unitwherein standard tools provided by dental design software operated byexecutable instructions, such as those seen in the screen shot of FIG.11, were available to form the virtual denture teeth designs. A virtualgingival line was created on the upper and lower teeth sets of eachvirtual denture design. Using the design software, points were applied,for example, in multiple locations on the buccal and lingual surfaces ofeach tooth of the virtual teeth sets, as well as points corresponding tothe interproximal regions. Using design software, the points were joinedwith an intersecting line to form a virtual gingival boundary thattraversed adjacent teeth, across the entire teeth set to connectadjacent teeth. The teeth of the virtual denture teeth designscorrespond to the teeth used in the wax set-ups which were Kenson®denture teeth (Myerson, LLC.).

A plurality of virtual denture teeth designs were formed in this manner.The resulting virtual denture teeth designs were saved to a memory of acomputing system, examples of which are illustrated in Table 1. Withreference to Table 1, measurements of the virtual denture teeth designwere obtained. Molar-to-molar measurements represent the widthmeasurements across an arch from the second molar to the second molar,measured in millimeters (mm) The incisive papilla distance representsthe distance (mm) from the anterior of the design corresponding to theapproximate location of where the incisive papilla will be located, to aposterior position that corresponds approximately to the center pointbetween the second molars.

Virtual denture teeth design #1 (Table 1), is formed having virtualteeth set in a fixed ovoid arch shape. The teeth were oriented in afixed position corresponding to a masculine arrangement of teeth.Virtual denture teeth designs 2-4 exemplify teeth sets that werearranged to accommodate an ovoid arch, and having teeth aligned in afeminine arrangement. Virtual designs numbers 2-4 exemplify designshaving similar arch shape and teeth arrangements made in multiple sizes.For example, the vertical dimension of occlusion (VDO) differs in thedesigns even though the molar-to-molar distances are the same fordesigns 3 and 4. The differences between the designs accommodatepatients, for example, having similarly sized arches when measuredacross the arch, but may require different sized teeth to accommodatevariances in VDO. When comparing designs #2 and 3, design #3accommodates a slightly longer overall arch length, however, both havethe same measurement from anterior to posterior (incisive papilladistance).

Design numbers 5-7 described virtual denture teeth designs that alsoaccommodate an ovoid arch. The teeth sets are aligned in a fixedposition in an ideal orientation. Three sizes of the ovoid-idealarrangement is shown. The design had variations in molar-to molardistance, and different anterior to posterior distances; the VDO is thesame for designs 5 and 6, and smaller for design 7. Moreover, designdetails are set forth for some embodiments including tapering (#7) andsquare (#9) feminine arrangements, and lingualized (#10) and cross-bite(#11) arrangements.

Table 1 outlines examples of the virtual denture teeth designs. Themeasurements in Table 1 are specific to the upper portion of a dentureteeth design corresponding to a maxillary arch design, and represent afull set of upper teeth. The examples in the table are not intended tobe limiting, and designs having further variations in sizes wereprepared for each arch shape and teeth alignment.

TABLE 1 Examples of Virtual Denture Teeth Designs. Virtual DentureMolar-to- Incisive Teeth Teeth Molar Papilla Design Orientation Arrange-Distance* Distance** VDO*** # Arch Shape ment (mm) (mm) (mm) 1 ovoidMasculine 49 40 19 2 ovoid Feminine 49 40 19 3 ovoid Feminine 50 40 20 4ovoid Feminine 50 44 22 5 ovoid Ideal 48 41 22 6 ovoid Ideal 50 40 22 7ovoid Ideal 53 42 20 8 tapering Feminine 47 44 21 9 square Feminine 4934 22 10 lingualized n/a 55 42 20 11 cross-bite n/a 53 44 21 *distancebetween second molars of upper arch in millimeters (mm). **distancebetween incisive papilla and center point between molars in mm.***VDO—vertical dimension of occlusion measured in mm.

Each virtual denture teeth design comprises both an upper part,corresponding to a virtual teeth set for an upper arch, and a lower partcorresponding to a virtual teeth set for the lower arch. The resultingvirtual teeth designs were saves as digital data files that may belocated within a design library stored locally or remotely, andaccessible via network interface.

Example 2

A functional fitting replica denture according to one embodiment wasdesigned as described herein.

Impressions of an edentulous patient's maxillae and mandible were takenat a dentist's office and a stone model was formed. The stone model wasscanned with a desk top scanner and data was uploaded to softwareprogram for forming a virtual denture (3 Shape desk top scanner andDental Designer™ software program).

Measurements from the digital image of the scanned stone model weretaken as follows. Tuberosity-to-tuberosity distance was measured to beapproximately 46 mm, when measure across the width of the upper arch.The tuberosity distance corresponds approximately to the distancebetween right and left second molars of the upper arch, as measureddirectly across the width of the arch impression. The retromolarpad-to-retromolar pad distance was measured to be approximately 49 mm,when measured across the width of the lower arch. The retromolar paddistance corresponds approximately to distance between the locations ofsecond molars on the lower arch, as measured directly across the widthof the arch impression. The vertical dimension of occlusion was measuredto be about 24 mm. Distance between the incisive papilla in the anteriorof the mouth, and a posterior point mid-way between the right and lefttuberosity locations when measured across the width of the arch, wasmeasured to be about 40 mm. The upper and lower portions of the digitalimage of the scanned stone model were marked for location of a gingivalregion using customary software design tools.

A virtual denture was constructed on a computer system on to whichdental restoration software was loaded, as follows. The shape of thepatient's arch was determined to be ovoid, and the instructions from thedentist requested that the denture teeth be arranged in an ideal tootharrangement. The patient data described above were used to select apre-designed virtual denture teeth design from a plurality of designsfrom a design library that was stored on the computer. The stone modelwas observed to confirm the shape of the patient's ridge as an ovoidshape. VDO measurements and molar-to-molar distances were used to selecta design having an appropriate size from among the predesigned virtualdenture teeth designs of an ovoid shape having teeth in an idealarrangement (i.e., design #5-7 in Table 1). A virtual denture teethdesign #5 in Table 1 was selected based on arch shape (ovoid), teetharrangement (ideal), and similarity in size to the features measured.The selected pre-designed virtual denture teeth design comprised a fullset of teeth (upper and lower arches) that were prearranged in a fixedposition having an orientation that corresponds to the ovoid arch shape.The pre-positioned teeth were aligned in an ideal arrangement, with theteeth being in a fixed position relative to each other.

The data file representing the virtual denture teeth design #5 wasretrieved and aligned with a data file containing the scan data of thepatient's stone model, in accordance with the dental design softwareprogram. Alignment of the virtual denture teeth design in relation tothe patient's scanned arches was optimized using a computer mouse tomake adjustments as seen on the display unit. The virtual denture teethdesign was positioned in proper alignment with the scan of the patient'sarches by rotating and moving the design (left-right, up-down, andside-to-side) as a single unit, until the best alignment relative to thearches was achieved. Because the teeth were in a fixed position on afixed arch shape, upon rotation of the design, none of the teeth of theteeth set moved separately from the unit. No modifications to individualteeth orientation or alignment, or arch shape and size were made.

The virtual denture teeth design had a preconfigured virtual gingivalboundary line. After aligning the image of the patient data file withthe image of the virtual denture teeth design, the virtual gingiva wasautomatically generated in a single step according to the preconfiguredgingival boundary of the virtual denture teeth design and the virtualgingiva of the image of the patient's stone model. A virtual gingiva wasgenerated that traversed adjacent teeth and virtual interdental papillaewere populated. Minor modifications to the gingival, such as addingadditional gingival detail such as festooning was quickly accomplishedwith the aid of a computer mouse, in accordance with tools provided bythe dental design software program. The resulting virtual gingivacorresponded to the virtual stone model and therefore a characteristicof the patient's oral anatomy was transferred to the virtual design. Thevirtual base of the virtual stone model of the edentulous patient wascut away using available software tools, leaving the virtual gingiva andvirtual denture teeth, and the virtual denture was completed. Data filescorresponding to the upper teeth, lower teeth, upper gingiva and lowergingiva were stored in a memory device.

The upper gingival region data file and upper virtual teeth data filewere merged; the lower gingival region data file and lower virtual teethdata file were merged by the computing system. Resulting virtual denturefiles were transmitted to a 3D printing system (3D Objet 500, byStratasys), and using an acrylic-based polymer (VeroDent™ polymer, byStratasys, Minneapolis, Minn.), were converted to printed upper andlower portions of a physical model of the virtual denture. The physicalmodel corresponded to the size and shape of the patient's oral anatomy,having one portion fitting securely onto the upper ridge, and a separatesecond portion fitting securely onto the lower ridge, of the edentulouspatient. The physical model comprised a 3D printed replica of thevirtual denture, having the gingival architecture and soft tissuefeatures of the patient which was replicated from the patient's stonemodel. The thickness of the physical model was approximately the same asthe thickness of a final denture.

A mold of a portion of the 3D printed physical model was madecorresponding to the cuspids (canines), lateral incisors, and centralincisors, as well as a portion of the posterior teeth adjacent theanterior teeth (i.e., the first and/or second premolars), as follows.Mold material comprising a vinyl polysiloxane lab putty (Capture®Impression Materials, by Glidewell Direct) was pressed around the upperand lower anterior regions of the 3D printed physical model. The moldcovered the teeth regions and surrounding gingival area above the teethand well as a portion of the soft palate on the upper 3D printedportion. Upon hardening, the mold was removed and comprised recessionscorresponding to the teeth and a replica of the surrounding gingiva ofthe physical model. The mold further comprised a relief that includedgingival details and soft tissue characteristics unique to the gingivalarchitecture of the patient.

A portion of the 3D printed physical model was removed with a handpiecefor use in denture finishing and bur. On each of the printed upper andlower portions, the printed material was removed in teeth regions thatcorresponded to the upper and lower central incisors, lateral incisorsand canines to form a gap. Additional printed material was removedcorresponding to a portion of gingiva adjacent the printed teeth regionsthat were removed. By removing printed material, a flat, planar ridgewas formed on each of the upper and lower printed portions in the regionthat corresponded to the gingival regions. Flat ridges bridged the innerand outer gingival areas of both the upper and lower printed portions.Because the ridge was substantially flat, the physical model lackedalveolar sockets; thus, no holes were formed to insert the actualdenture teeth. Additionally, a planar indentation was formed around thegap on the upper and lower portions by removing material in the gingivalregions adjacent to the gap, thus, forming the gingiva indentation. Thegingiva indentation continued around the border of the gap and extendedto a finish line. The gingiva indentation depth was less than thethickness of the physical model.

Denture teeth (Kenson® teeth, distributed by Myerson LLC) thatcorresponded to the virtual denture were inserted into the recesses ofthe mold. The mold and the physical model were assembled, with thedenture teeth positioned in the gap of the physical model. Wax wasinjected through an injection channel in the mold with a syringe. Afterthe wax material hardened, the mold was removed from the physical modelrevealing the functional fitting replica denture. The functional fittingreplica denture was formed having actual denture teeth partiallyembedded in wax in the gap on the upper and lower portions of thephysical model. The portion of the gap not filled by the denture teethwas substantially filled with the wax which abutted the flat ridge. Thecrown of the denture teeth was not embedded in the wax. The wax was apink or flesh color resembling the color of a patient's gingiva, and hadgingival features unique to the patient that were replicated by themold. The gingival structures of the patient, replicated in the wax,formed a gingival architecture made of the formable material. The sideof the tooth opposite the occlusal surface, was adjacent thesubstantially flat, planar ridge with a wax layer between the topsurface of the denture teeth and the printed ridge. The position andorientation of the teeth was substantially similar to the position ofthe teeth of the printed model and the virtual denture design. Thedenture teeth were held in place adjacent the flat ridge by the wax.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It should beemphasized that the above-described embodiments of the presentdisclosure are merely possible examples of implementations, merely setforth for a clear understanding of the principles of the disclosure.Many variations and modifications may be made to the above-describedembodiment(s) without departing substantially from the spirit andprinciples of the disclosure. It will be appreciated that several of theabove-disclosed and other features and functions, or alternativesthereof, may be desirably combined into many other different systems orapplications. All such modifications and variations are intended to beincluded herein within the scope of this disclosure, as fall within thescope of the appended claims.

We claim:
 1. A denture device comprising a first portion comprising aphysical model of a denture that fits securely in the mouth of a patientcomprising a first material, comprising first and second posterior teethregions, a gap between the posterior teeth regions corresponding to ananterior teeth region; and an anterior gingival region adjacent the gap;and a second portion comprising a second material that is different fromthe first material, that at least partially fills the gap in thephysical model and forms a gingival region; and a plurality of anteriordenture teeth positioned in the gap, each of the denture teethcomprising a portion that is embedded in the second material.
 2. Thedenture device of claim 1, wherein the first material comprises a 3Dprintable polymeric material.
 3. The denture device of claim 1, whereinthe second material comprises a formable material.
 4. The denture deviceof claim 1, wherein the plurality of denture teeth are adjacent a ridgethat is between the posterior teeth regions and adjacent an anteriorgingival region.
 5. The denture device of claim 1, wherein the secondportion comprises a gingival architecture formed from the secondmaterial replicating a portion of the patient's gingival structures. 6.The denture device of claim 1, the first material comprising a gingivaindentation surrounding a portion of the gap, the gingiva indentation atleast partially filled with the second material.
 7. The denture deviceof claim 1, wherein the plurality of anterior denture teeth are selectedfrom central incisors, lateral incisors, and cuspids.
 8. The denturedevice of claim 1, wherein the plurality of anterior denture teethcomprises central incisors, lateral incisors, and cuspids.
 9. Thedenture device of claim 1, further comprising one or more posteriordenture teeth.
 10. The denture device of claim 1, comprising an upperportion of a denture device, a lower portion or a denture device, or anupper and a lower portion of a denture device.
 11. The denture device ofclaim 1, comprising an upper portion of a denture device or a lowerportion of a denture device, and further comprising an occlusalrecording device comprising a deformable material that fits on themandible of the patient.
 12. A denture device comprising a physicalmodel of a denture that fits securely in the mouth of a patient,comprised of a first material comprising lingual and buccal gingivalregions and a ridge between the gingival regions; one or more dentureteeth adjacent the ridge of the physical model; and a formable, secondmaterial that abuts the ridge, and a portion of the tooth of the one ormore denture teeth that is adjacent the ridge is embedded in theformable material, and the formable material replicates a portion of thepatient's gingival architecture.
 13. The denture device of claim 12,wherein physical model comprises a gingival indentation and formable,second material that is introduced in the gingival indentationreplicates a portion of the patient's gingival architecture.
 14. Thedenture device of claim 12, wherein the crown of the denture teeth isnot embedded in formable material.
 15. The denture device of claim 12,wherein the physical model comprises one or more teeth regions selectedfrom an anterior teeth region, a posterior teeth region, or bothanterior and posterior teeth regions.
 16. The denture device of claim12, wherein the physical model comprises a gap that provides a space inthe physical model for one or more denture teeth.
 17. The denture deviceof claim 12 wherein the physical model comprises a base with an innershape that fits securely on the maxillae or mandible of the patient. 18.The denture device of claim 12, wherein the denture device comprises apartial denture.
 19. A denture device comprising a physical model of adenture that fits securely in the mouth of a patient comprised of afirst material that comprises anterior and posterior teeth regions, agingival region adjacent the teeth regions that substantially replicatesa portion of the patient's gingival architecture, and a portion of thegingival region comprising a gingival indentation; and a formable,second material introduced in the gingival indentation, having astructure that replicates a portion of the patient's gingivalarchitecture.
 20. The denture device of claim 19, wherein the gingivalindention surrounds the anterior teeth regions of the physical model.